Floxsafe/Floxsafe IV

Moxifloxacin (tab: HCl)

Adult (>18 yr) w/ bacterial infections eg, acute bacterial sinusitis; acute bacterial exacerbation of chronic bronchitis; community acquired pneumonia; complicated skin & skin structure infections (IV); mild to moderate pelvic inflammatory disease (ie, infections of female upper genital tract, including salpingitis & endometritis) in patient ≥18 yr. Floxsafe IV Complicated intraabdominal infections.

Floxsafe Adult 400 mg orally once daily. Duration: Acute exacerbation of chronic bronchitis 5-10 days. Community acquired pneumonia 7-14 days (sequential oral therapy following IV administration). Acute bacterial sinusitis 7 days. Mild to moderate pelvic inflammatory disease 14 days. Complicated skin & soft tissue infection 7-21 days (sequential oral therapy following IV administration). Floxsafe IV Adult 400 mg IV infusion over 60 min once daily. Duration: Sequential therapy: Acute bacterial sinusitis 7-14 days. Acute bacterial exacerbation of chronic bronchitis 5 days. Pneumonia 7-14 days. Uncomplicated skin & skin structure infections 7 days. Complicated skin & skin structure infections 7-21 days. Complicated intraabdominal infections 5-14 days.

May be taken with or without food: Swallow tab whole w/ sufficient liqd.

Hypersensitivity to moxifloxacin or other quinolones. Patients w/ history of tendon disease/disorder related to quinolone treatment; congenital or documented acquired QT prolongation; electrolyte disturbances particularly uncorrected hypokalaemia; clinically relevant bradycardia; clinically relevant HF w/ reduced left-ventricular ejection fraction; previous history of symptomatic arrhythmias. Not to be used concurrently w/ other drugs prolonging the QT interval. Hepatic impairment (Child-Pugh C) & patients w/ increased transaminases >5-fold ULN. Pregnancy & lactation. Childn <18 yr.

Hypersensitivity & allergic reactions after 1st administration. Not recommended for use in MRSA infection treatment. Patients w/ ongoing proarrhythmic conditions (especially women & elderly) eg, acute myocardial ischaemia or QT prolongation; w/ CNS disorders or other risk factors predisposing to seizures or lower seizure threshold. Fulminant hepatitis. Perform LFTs/investigations in case of liver dysfunction indications. Bullous skin reactions eg, SJS or TEN. Peripheral neuropathy. Psychotic patients or those w/ history of psychiatric disease. Discontinue if depression or psychotic reactions progressed to suicidal thoughts & self-injurious behaviour (eg, suicide attempts). Consider antibiotic-associated diarrhoea (AAD) & antibiotic-associated colitis (AAC), including pseudomembranous colitis & Clostridium difficile-associated diarrhea in the diagnosis of patients who develop serious diarrhea during or after therapy. Discontinue use if AAD or AAC is suspected or confirmed. CI w/ peristalsis-inhibiting drugs in patients who develop serious diarrhoea. Patients w/ myasthenia gravis; family history of or actual G6PD. Increased risk of tendinitis & tendon rupture in elderly, in those treated concurrently w/ corticosteroids, patients w/ kidney, heart & lung transplants (for IV only); discontinue at the 1st sign of pain & inflammation & rest the affected limbs. Avoid exposure to either UV irradiation or extensive &/or strong sunlight during treatment. May interfere w/ Mycobacterium spp culture test. May impair ability to drive or operate machinery due to CNS reactions. Prolongation of QTc interval & potentially QTc-prolongation-related clinical conditions in women & the elderly. Floxsafe Not recommended for use in monotherapy of mild to moderate pelvic inflammatory disease. Can reduce K levels. Patients w/ special cSSSi. Maintain adequate fluid intake. Visual impairment or any effects on the eyes. Carefully monitor blood glucose in diabetic patients. Not recommended in patients w/ complicated pelvic inflammatory disease (eg, associated w/ tubo-ovarian or pelvic abscess). CI in childn & adolescents <18 yr. Elderly w/ renal disorders who are unable to maintain adequate fluid intake. Occurrence of dysglycemia in elderly diabetic patients concomitantly using oral hypoglycemic agent (eg, sulfonylurea) or insulin. Floxsafe IV Medically consider Na intake in patients w/ congestive cardiac failure, renal impairment, nephritic syndrome.

Mycotic superinfections (eg, oral & vag candidiasis); headache, dizziness; prolonged QT in patients w/ hypokalaemia; nausea, vomiting, GI & abdominal pain, diarrhoea; aminotransferase increased. Floxsafe IV Inj & infusion site reactions.

Increased oral anticoagulant activity. Floxsafe Additive effect on QT interval prolongation w/ other medicinal products that may prolong the QTc interval eg, class IA (eg, quinidine, hydroquinidine, disopyramide) & III (eg, amiodarone, sotalol, dofetilide, ibutilide), anti-arrhythmics, antipsychotics (eg, phenothiazines, pimozide, sertindole, haloperidol, sultopride), TCAs, certain antimicrobial agents (eg, saquinavir, sparfloxacin, erythromycin IV, pentamidine, antimalarials particularly halofantrine), certain antihistaminics (eg, terfenadine, astemizole, mizolastine) & cisapride, vincamine IV, bepridil, diphemanil. Pronounced prevention of absorption & reduced systemic availability w/ charcoal. Increased C_max of digoxin. Floxsafe IV May cause hypokalaemia w/ thiazide & loop diuretics, corticosteroids, ACTH, & glycyrrhizin. May cause convulsions w/ NSAIDs of phenylacetic acid or propionic derivatives (eg, roxoprofen).

Quinolones

J01MA14 - moxifloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.

Rx